K902263 is an FDA 510(k) clearance for the OPTILASE MODEL 1000 ND:YAG LASER ADD'L INDICATION. This device is classified as a Pipette, Sahli (Class I - General Controls, product code GGX).
Submitted by Trimedyne, Inc. (Tustin, US). The FDA issued a Cleared decision on July 23, 1990, 63 days after receiving the submission on May 21, 1990.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.6160.
| 510(k) Number | K902263 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 21, 1990 |
| Decision Date | July 23, 1990 |
| Days to Decision | 63 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | — |
| Product Code | GGX — Pipette, Sahli |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 864.6160 |